A comparative study of a nerve block therapy with and without a deeply inserted acupotomy applied to hyeopcheok points for lumbosacral radiculopathy: Safety, effectiveness, cost-effectiveness (a randomized controlled, two-arm, parallel study, pilot study, assessor-blind).

INTRODUCTION: The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.

Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study.

INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.

A scoping review of acupuncture insurance coverage in the United States.

BACKGROUND: Increasing access to non-pharmacologic pain management modalities, including acupuncture, has the potential to reduce opioid overuse. A lack of insurance coverage for acupuncture could present a barrier for both patients and providers. The objective of this scoping review was to assess the existing literature on acupuncture insurance coverage in the United States and to identify knowledge gaps and research priorities. METHODS: We utilized the Arksey and O'Malley framework to guide our scoping review methodology. We followed a pre-determined study protocol for the level-one abstract and level-two full text screenings. We synthesized information into subject-area domains and identified knowledge gaps. RESULTS: We found a lack of published data on acupuncture coverage in 44 states, especially in the Midwest and the South. Where data were available, a large proportion of acupuncture users did not have insurance coverage. Consumer demand, state mandates, and efforts to reduce opioid use were motivations to cover acupuncture. Licensed acupuncturists were less likely to be reimbursed and were reimbursed at lower rates compared to physicians. Reported barriers encountered when implementing coverage included a lack of providers, challenges determining when to offer non-pharmacologic treatments, and a lack of evidence for clinical efficacy and cost-effectiveness. CONCLUSION: We found a lack of recent publications and data comparing regional coverage in the United States. A key challenge is that commercial insurance plan data are not in the public domain. Further research should assess insurance coverage implementation for acupuncture and measure the impact of policy changes on acupuncture utilization and rates of opioid overuse.

Tackling health inequity: a commentary on the potential of acupuncture to improve health outcomes of marginalised populations.

BACKGROUND: Health inequities or disparities challenge governments and public health systems, impacting health service delivery worldwide. Inherent disadvantage linked to the social determinants of health is intrinsic to the health outcomes among society's marginalised and most vulnerable members. It is acknowledged that marginalised individuals present with higher levels of chronic disease, multi-morbidities and adverse health behaviours than their non-disadvantaged peers. Marginalised individuals and communities present with complex health problems and often receive poor quality or inadequate health care that is unable to meet their needs, leading to stigmatisation and perpetuating the cycle of disadvantage. DISCUSSION: Emerging research indicates that there may be a role for acupuncture in managing the health needs of marginalised populations and that when historical barriers to accessing acupuncture treatment (such as awareness, availability and affordability of this therapy) are removed, certain marginalised populations are open to engaging with acupuncture treatment. Acupuncture has been used by low-income, refugee, veteran and ethnic minority groups to manage chronic pain, substance use disorders, stress and the impacts of trauma in conventional health settings such as community clinics and hospitals. There is the suggestion that integrative health settings and group treatment models may improve access and uptake of acupuncture among marginalised groups. CONCLUSION: Evidence suggests that the sociodemographic profile of acupuncture users is diverse and acupuncture therapy holds potential value in the treatment of marginalised populations. Further research that investigates reframing and expanding the scope of practice for acupuncture is timely and may contribute to tackling health inequity.

Economic evaluation alongside a randomised controlled trial to assess the effectiveness and cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy.

OBJECTIVE: To assess the cost-effectiveness of acupuncture in the management of chemotherapy-induced peripheral neuropathy (CIPN) in Hong Kong. METHODS: A within trial cost-utility analysis with the primary endpoint for the economic evaluation being the Quality Adjusted Life Year (QALY) and associated Incremental Cost Effectiveness Ratio (ICER) over 14 weeks of treatment. A secondary cost-effectiveness analysis was undertaken with the endpoint being change in pain as measured on the Brief Pain Inventory (BPI). RESULTS: Eighty-seven patients were randomised to acupuncture or usual care. Acupuncture resulted in significant improvements in pain intensity (8- and 14-week mean changes compared to usual care of -1.8 and -1.8, respectively), pain interference (8- and 14-week mean changes compared to usual care of -1.5 and -0.9, respectively) and indicators of quality of life and neurotoxicity-related symptoms. However, in the economic evaluation there was little difference in QALYs between the two arms (mean change 0.209 and 0.200 in the acupuncture and usual care arms, respectively). Also, costs yielded deterministic ICERs of HK$616,965.62, HK$824,083.44 and HK$540,727.56 per QALY gained from the health care provider perspective, the societal perspective and the patient perspective, respectively. These costs are significantly higher than the cost-effectiveness threshold of HK$180,450 that was used for the base case analysis. CONCLUSION: While acupuncture can improve symptoms and quality of life indicators related to CIPN, it is unlikely to be a cost-effective treatment for CIPN-related pain in health care systems with limited resources. TRIAL REGISTRATION NUMBER: NCT02553863 (ClinicalTrials.gov) post-results.

Acupuncture in the management of trigeminal neuralgia.

BACKGROUND: We aimed to assess the standing of acupuncture as a clinical tool in the management of trigeminal neuralgia against the current first-line drug treatment (carbamazepine) and the most effective surgery (microvascular decompression (MVD)). METHODS: Data regarding efficacy, side effects and cost were compiled for each of these three modalities from the PubMed and Cochrane Library databases. Patient stress was estimated according to Holmes and Rahe's Social Readjustment Rating Scale (SRRS). RESULTS: Acupuncture was not significantly more effective than its corresponding control (p = 0.088), but had the greatest efficacy (mean ± 95% confidence interval) of the modalities considered (86.5% ± 5.6% compared to surgery (79.3% ± 7.7%) and pharmacotherapy (71.7% ± 2.5%), respectively). Acupuncture also had fewer mean reported side effects (22.7% ± 5.9%) compared with surgery (25.3% ± 12.6%) and pharmacotherapy (88.8% ± 25.0%), and the lowest cost; after 5 years, the cost of acupuncture was estimated to be £750, compared to £1507.73 for carbamazepine and £4878.42 for MVD. Acupuncture was the least stressful according to the SRRS (53 points), whereas surgery was second most stressful (153 points) and pharmacotherapy was the most stressful intervention to patients (217 points). CONCLUSION: Acupuncture appears more effective than pharmacotherapy or surgery. Statistical analysis of side effects was not possible due to inconsistent reporting protocols, but the data suggest that acupuncture is considerably safer than pharmacotherapy or surgery. Acupuncture also appears to be the least expensive therapeutic modality to deliver long-term (65 weeks onwards), and our analysis indicated that it was less stressful to patients than pharmacotherapy or surgery. Further study into these areas and the practicality of its availability in the UK National Health Service (NHS) and other health systems is recommended.

The effectiveness and cost-effectiveness of motion style acupuncture treatment (MSAT) for acute neck pain: A multi-center randomized controlled trial.

BACKGROUND: Neck pain is a common complaint in the general population. Despite the consistent ongoing pain and the resulting economic burden on affected individuals, there have only been a few studies investigating the treatment of acute neck pain. This study aims to evaluate the effectiveness, safety, and cost-effectiveness of the motion style acupuncture treatment (MSAT) and acupuncture treatment for acute neck pain. METHODS: This 2-armed, parallel, multi-centered randomized controlled trial will be conducted at 4 community-based hospitals in Korea. A total of 128 subjects will be randomly assigned, at a 1:1 ratio, to the MSAT and the acupuncture treatment groups. Treatment will be administered 2 to 3 times a week for 2 weeks. The primary outcome will be the visual analog scale of neck pain on movement. The secondary outcomes will be the numeric rating scale of the neck, neck disability index, Northwick Park questionnaire, patient global impression of change, range of motion of the neck, 5-level EuroQol-5 dimension, 12-item Short-Form Health Survey, and EuroQol visual analogue scale. This protocol has been registered at the Clinicaltrials.gov (NCT04539184). DISCUSSION: To our knowledge, this study is the first well-designed multi-centered randomized controlled trial to evaluate the effectiveness, safety, and cost-effectiveness of MSAT on acute neck pain. The results of this study will be useful for clinicians in primary medical institutions that frequently treat acute neck pain patients and for policymakers working with national health insurance.

The efficacy and safety of acupuncture and moxibustion combined with western medicine for obsessive-compulsive disorder: A protocol for systematic review and meta-analysis.

BACKGROUND: Obsessive-compulsive disorder is common, chronic mental disorder, which is characterized by recurrent, unwanted, or intrusive thoughts and repetitive behaviors or mental action. Acupuncture and moxibustion, as a popular form of complementary and alternative therapy, have the advantages of low side effects, high safety, and low cost. The research showed that acupuncture and moxibustion have a good clinical efficacy on obsessive-compulsive disorder. However, there is no literature to systematically evaluate the efficacy and safety of acupuncture and moxibustion in treating obsessive-compulsive disorder. Thus, this study is aimed to evaluate the efficacy and safety of acupuncture and moxibustion for obsessive-compulsive disorder patients, providing reliable evidence for clinical application. METHODS: Randomized controlled trials of acupuncture and moxibustion combined with western medicine for the treatment of obsessive-compulsive disorder will be searched in the databases including PubMed, EMBASE, the Cochrane library, Web of science, China National Knowledge Infrastructure(CNKI), WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database (CBM) from inception to June, 2020. In addition, Baidu, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain the gray literature and relevant data that have not yet been published. Two qualified researchers will extract data and assess the risk of bias from included studies dependently. Statistical analysis is performed in RevMan 5.3 software. RESULTS: The efficacy and safety of acupuncture and moxibustion combined with western medicine for obsessive-compulsive disorder will be assessed based on the total effective rate, Hamilton Anxiety Scale score, Hamilton Rating Scale for Depression score, Clinical Global Impression score, side effects, and so on. CONCLUSIONS: The proposed systematic review and meta-analysis of acupuncture and moxibustion combined with western medicine for treating obsessive-compulsive disorder is expected to provide reliable evidence for clinical application. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/CDGTW.

Acupuncture reduced the medical expenditure in migraine patients: Real-world data of a 10-year national cohort study.

OBJECTIVES: According to the data of Organisation for Economic Cooperation and Development, almost all the countries got increased medical expenditures in these years. Among the diseases, migraine is a condition that affects predominantly young and middle-aged people. It results in great economic losses. So we perform this research to investigate the acupuncture effect of reducing medical expenditure and medical resources use. PERSPECTIVE: Acupuncture is a non-pharmacologic treatment and it became popular in recent years. In Taiwan, about 13% migraine patients visited acupuncture doctor. We hypothesized that the acupuncture had the additional effect than the medical treatment. SETTING: We analysed the economic cost and medical visits in the real word. METHODS: We used national cohort data from Taiwan, retrospectively gathered between 2000 and 2010. We selected newly diagnosed migraine patients who were diagnosed by registered neurologists formally licensed by the Taiwan Neurological Society. We divided these patients into two groups: with and without acupuncture treatment. The main outcome was medical expenditures and visits within 1 year after acupuncture. RESULTS: In migraine patients who received acupuncture treatment, medical expenditures on emergency care and hospitalization were significantly lower than the group without acupuncture treatment. CONCLUSION: According to our real-world data, acupuncture can reduce the medical expenditure in migraine patients within 1 year after diagnosis. For the health policy maker, it is cost effective to encourage combining acupuncture and western medicine to treat migraine patients. For the doctors in routine clinical practice, who may consider to consult acupuncture doctors to deal with the migraine patients together.

Acupuncture for erectile dysfunction in post-stroke patients: Study Protocol Clinical Trial (SPIRIT Compliant).

INTRODUCTION: Erectile dysfunction refers to the continued inability of the penis to reach and maintain sufficient erections to achieve a satisfactory sex life and last at least 6 months. As part of traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate, the exact effect of acupuncture on the clinical efficacy of patients with Post-stroke Erectile dysfunction (PSED), this experiment uses randomized controlled experiments. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 103 patients who are diagnosed with PSED. Simple randomization to conventional treatment with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional treatment. The selection of outcomes will be evaluated by International Erectile Function Index-5 (IIEF-5) score at week 8. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with PSED. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000030231, Registered on February 25, 2020.

A randomized controlled clinical study of acupuncture therapy for Seborrheic alopecia in young and middle ages: Study protocol clinical trial (SPIRIT compliant).

INTRODUCTION: Seborrheic alopecia (SA) has clinical manifestations, duration of disease, and priorities. In the current situation where there are many and complicated clinical treatments, Western medicine treatment can delay and control the development of the disease and promote hair regeneration. However, some patients may aggravate symptoms after taking the drug, and the condition is easy to repeat after stopping the drug. Acupuncture is an important method for non-surgical treatment of SA, and it has various methods, low side effects, high safety, and simple and economical. Therefore, we will use a clinical randomized controlled study to explore the effect of acupuncture on SA, and provide a new idea and reference for the treatment of this disease. METHODS/DESIGN: We will select 60 patients diagnosed with SA. They will be randomly divided into intervention group and control groups. The control group will be given conventional treatment measures. The intervention group will receive acupuncture. Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with SA. TRIAL REGISTRATION NUMBER: CTR2000030430.

Acupuncture combined with tamsulosin hydrochloride sustained-release capsule in the treatment of chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common urinary system disease in men. As part of traditional Traditional Chinese medicine, acupuncture has been widely used in clinical practice. In order to evaluate the exact effect of acupuncture on the clinical efficacy of CP/CPPS, this experiment uses randomized controlled experiments. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 166 patients who are diagnosed with CP/CPPS. Simple randomization to conventional drug treatment with a 1:1 allocation ratio will be used. Ten 30-minute acupuncture sessions will be provided to patients assigned to the Intervention group. All participants will continue to receive conventional drug treatment. The selection of outcomes will be evaluated by Health's Symptom Score Index (NIH-CPSI) score at week 4. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with CP/CPPS. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR1900021132, Registered on 29 January 2019.

Acupuncture for the treatment of ankle sprain: A protocol for a systematic review and meta-analysis: study protocol.

BACKGROUND: Ankle sprain is one of the most common musculoskeletal injuries in our daily life, which may lead to chronic ankle instability, reducing the quality of patients' life and imposing a heavy burden on social medical security system. There are many kinds of methods treating ankle sprain, which can be divided into the conservative treatments and surgical intervention. Acupuncture is one of the conservative treatments for ankle sprain, especially in China. Therefore, we perform a systematic review and meta-analysis to evaluate the evidence for acupuncture's effectiveness, safety and cost benefits for the treatment. METHODS: For the acquisition of required data of eligible randomized controlled trials (RCTs), literature search will be undertaken from the following database: PubMed, Embase, Web of Science, The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov, Chinese National Knowledge Infrastructure (CNKI), VIP Database, and Wanfang database. Quality assessment of the included studies will be independently performed according to the Cochrane Risk of Bias Tool by 2 investigators and the level of evidence for results will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. Statistical analysis will be conducted with Revman 5.3. RESULTS: From the study we will assess the effectiveness, safety and cost benefit of acupuncture on pain relief and functional improvement in patients with ankle sprain. CONCLUSION: The conclusion of this study will provide evidence to ensure the effectiveness, safety and cost benefits of acupuncture on ankle sprain, which can further guide the selection of appropriate interventions. PROSPERO REGISTRATION NUMBER: CRD42018116829.

Group Acupuncture Model in a Cancer Institute: Improved Access and Affordability.

Cancer patients may experience significant symptom mitigation from acupuncture. However, this service may not be easily accessible or affordable at all cancer institutions. The development of a group acupuncture program provided one institution with improved availability, lower cost to patients, and a foundation for oncology acupuncture research. This care delivery model was deployed at a large southeastern cancer institution within a multistate academic-community hybrid hospital system. The cancer institute serves >15,000 patients annually. Acupuncture is provided through the institute's Integrative Medicine section of the Department of Supportive Oncology. The purpose of this commentary is to describe the successful transition from an individual to group acupuncture model at this cancer institute. With the implementation of group acupuncture, patient visits increased 275% from individual care delivery. Although successful implementation of a group acupuncture model may be affordable and clinically positive, the authors also share unique challenges learned through the development and expansion of this program.

Acupuncture price in forty-one metropolitan regions in the United States: An out-of-pocket cost analysis based on OkCopay.com.

Few studies have focused on the cost of acupuncture treatments although acupuncture has become popular in the United States (U.S.). The purpose of the current study was to examine the out-of-pocket costs incurred from acupuncture services based on an online website, OkCopay.com. We examined descriptive statistics (range, median and 20% intervals) for the cost of acupuncture "first-time visits" and "follow-up visits" in 41 metropolitan regions in the U.S. The acupuncture prices of 723 clinics throughout 39 metropolitan regions were included, except for Birmingham, Alabama and Detroit, Michigan as there was no online data available at the time of the study for these two regions. The cost range for a first-time acupuncture visit was $15-400; the highest median was $150 in Charleston, South Carolina, while the lowest was $45 in St. Louis, Missouri. The top 10 cities for the highest median were: Baltimore, Washington, D.C., New York, San Francisco, San Jose, Boston, Atlanta, Seattle, Portland and Indianapolis, with the median $120, while the median for all 723 clinics was $112. For the follow-up visits, the cost range was $15-300; the highest median was $108 in Charleston, South Carolina, and the lowest $40 in Miami, Florida. The 10 cities with highest median follow-up acupuncture visit costs were: New York, Baltimore, New Orleans, Washington, D.C., Philadelphia, San Francisco, San Jose, Seattle, Boston and Atlanta, with the median $85, while for all 723 clinics the median price was $80. The estimation of the average gross annual income of each acupuncturist from the regions studied was $95,760, while the total annual cost of patients seeking acupuncture services in the U.S. was about $3.5 billion in 2018.

Time to Align Coverage with Evidence for Treatment of Back Pain.

Despite improved knowledge about the benefits and harms of treatments for chronic back pain in the past several decades, there is a large and consequential mismatch between treatments found safe and effective and those routinely covered by health insurance. As a result, care for back pain has, if anything, deteriorated in recent decades-expenses are higher, harms are greater, and use of ineffective treatments is more common. Deficiencies in health care delivery processes and payment models are centrally involved in the failure to improve care for back pain. A key step for accelerating progress is changing insurance coverage policies to facilitate use of the safest and most helpful approaches while discouraging riskier and less effective treatments. Relatively simple changes in reimbursement policies may minimize harm and improve quality of life for many patients with chronic back and similar pain syndromes. Such changes might also reduce health care expenditures because the costs of treatments currently covered by insurance and their associated harms may well outweigh the costs of the relatively safe and effective treatments recommended by current guidelines but poorly covered by insurance. There is no justification for continuing the status quo-patients and clinicians deserve better.

The study protocol for a randomized, controlled trial of acupuncture versus a sham procedure versus standard care alone for the treatment of delirium in acutely hospitalized older adults with a medical illness.

BACKGROUND: Many hospitalized older adults experience delirium, but treatment options are limited. Acupuncture has been shown to improve cognitive function and reduce agitation in dementia. We hypothesize that acupuncture, when compared with a sham intervention, will reduce the duration and severity of delirium, normalize delirium biomarkers, and improve clinical outcomes related to delirium in acutely hospitalized older adults with a medical illness. METHODS: This three-arm, prospective, randomized, clinical trial will evaluate adults aged over 65 years who are acutely hospitalized to an internal-medicine ward and diagnosed with delirium or subsyndromal delirium. The 288 patients (96 in each of three groups) will be randomly allocated to receive either daily true acupuncture with usual care, a daily sham procedure with usual care, or usual care only in a 1:1:1 distribution for up to one week or until the patient is delirium-free for over 48 h. Other delirium and clinical interventions will remain unchanged. Delirium will be diagnosed using DSM-5 criteria and its severity will be assessed using the long Confusion Assessment Method Severity (CAM-S) tool. OUTCOMES: The primary study outcome will be the daily CAM-S score over 7 days between the three groups. Secondary outcomes will include time to first resolution of the delirium (over 7 days), the proportion of days spent delirium-free, daily antipsychotic use, daily pain scores, sleep quality, morning serum cortisol and T3 levels, and midnight urinary cortisol/creatinine ratio, all determined twice a week, and delirium-related complications. Hospital mortality, duration of hospital stay and functional status at discharge will also be compared between the three groups. Adverse events potentially related to acupuncture will be evaluated daily. The cost-effectiveness of acupuncture will be estimated. CONCLUSION: This novel randomized study will evaluate both the specific and the non-specific effects of acupuncture on delirium, and related outcomes, and its safety. Potential mechanism(s) of action for acupuncture in reducing delirium will be explored and healthcare-related costs estimated. Positive study results may prove pivotal in facilitating a multimodal, non-pharmacologic, integrative approach to delirium treatment among older, medical inpatients.